Development of a Therapeutic Education Program for Patients Operated for Prostate Cancer

Prostate Cancer Clinical Trial

— PEPs PROSTATE  

Official title:

Development of a Therapeutic Education Intervention Improving Sexuality in Patients With Prostate Cancer Treated With Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379260
• Other study ID #: 2014-11
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: February 25, 2016
• Start date: May 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The aim is to built a Therapeutic Education Program for patients treated with radical prostatectomy in order to improve their sexuality.

This study is carried out in two steps :

• Identification of specific educational objectives through a sociological study, with interviews and focus groups conducted and analyzed by a sociologist. Patients from the urology department of the hospital center (CH) Lyon Sud - Hospices Civils de Lyon (HCL) will be included

• Development of the program by a caregiver education expert (Centre Hygée), adapted partly from results of the qualitative study and partly from concepts and tools from the Education Sciences.

Description:

8 patients and 2 urologists will be interview to explore the educational needs and to create, expand and validate an interview guide. Exploratory interviews with urologists will address information given to patients on post radical prostatectomy sexual dysfunction, prescribing practices, monitoring therapy (PDE5 inhibitors, IIC, Vacuum), and patients adverse effects management.

Focus groups will be conduct to :

• Identify the representations associated with erectile dysfunction

• Identify the representations related to treatments for erectile dysfunction.

• Score patient knowledge about treatments and their managements.

• Identify common or original strategies to improve adherence, reduce side effects and overcome the disadvantages of the treatments.

• Assessing the needs and expectations of patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients followed in urology department Lyon Sud CH:

• Aged over 18 year

• Having a prostate cancer

• Treated with radical prostatectomy with or without conservation strips neuro vascular

• More than 1 month postoperative

• Having a normal preoperative erectile function defined by a score IIEF EF = 26.

• And who signed the informed consent form for participation in the study

Exclusion Criteria:

• Score preoperative IIEF EF <26

• Refusal of participation, signed consent major patients protected under guardianship.

• Patients unable to understand the course of the study

• Patient (s) with a documented history of cognitive or psychiatric disorders.

• Geographical remoteness of more than 100 Kms.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Interview with a sociologist

Locations

Country	Name	City	State
France	CH Lyon Sud	Pierre Bénite

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire	Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thematic and comparative analysis of the recorded interviews	Thematic and comparative analysis of the recorded interviews and transcribed favoring a thematic approach that linked the different elements of speech.	2 hours	No